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Monoclonal Antibodies
Atezolizumab +/− Selinexor for Sarcoma
Phase 2
Recruiting
Led By Alice P Chen
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault
Patients must have an advanced soft tissue sarcoma (not otherwise specified [NOS]) to be enrolled in the safety run-in
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing whether atezolizumab, either alone or combined with selinexor, is better than the current standard of care for alveolar soft part sarcoma.
Who is the study for?
Adults (18+) with alveolar soft part sarcoma, a rare cancer, who can't be cured by surgery. They should have measurable tumor growth and acceptable organ function. HIV-positive patients must have an undetectable viral load on therapy. Participants need to agree to use contraception if applicable and provide biopsy samples for research.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Atezolizumab alone or combined with Selinexor against standard treatments for shrinking tumors in alveolar soft part sarcoma. It explores how these drugs might help the immune system fight cancer or block proteins that aid in cancer cell growth.See study design
What are the potential side effects?
Atezolizumab may cause immune-related inflammation, fatigue, infusion reactions, while Selinexor could lead to nausea, vomiting, loss of appetite, weight loss, tiredness and changes in blood counts which can increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels or clearance, is within the required range.
Select...
I have an advanced soft tissue sarcoma.
Select...
My cancer is a type called alveolar soft part sarcoma and cannot be removed by surgery.
Select...
My ASPS is spreading and cannot be removed via surgery.
Select...
I am mostly self-sufficient and can carry out daily activities.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate
Secondary outcome measures
Progressive disease (PD)
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (atezolizumab)Experimental Treatment5 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I. Patients also undergo biopsy at baseline and cycle 3 day 1, CT and MRI at baseline, end of cycle 2, and every 2 cycles thereafter, and collection of blood samples throughout the study.
Group II: Arm I (atezolizumab, selienexor)Experimental Treatment6 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 8 of cycle 1, and then on day 1 of subsequent cycles. Patients also receive selinexor PO QW on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy at baseline, cycle 1 day 8 and cycle 3 day 1, CT and MRI at baseline, end of cycle 2, and every 2 cycles thereafter, and collection of blood samples throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Atezolizumab
2017
Completed Phase 3
~5860
Biospecimen Collection
2004
Completed Phase 2
~1730
Biopsy
2014
Completed Phase 4
~850
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,076 Total Patients Enrolled
Alice P ChenPrincipal InvestigatorNational Cancer Institute LAO
3 Previous Clinical Trials
153 Total Patients Enrolled
Geraldine O'Sullivan CoynePrincipal InvestigatorNational Cancer Institute LAO
4 Previous Clinical Trials
202 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had mild or moderate infection symptoms within the last 2 weeks.I have had treatment for any painful cancer spots before joining.I frequently need procedures to remove excess fluid from my chest or abdomen.I have had leptomeningeal disease.I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.I have not had major surgery in the last 28 days.I have had cancer other than ASPS before.I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives of the drug.I have a history of cancer.I have pain from my cancer that isn't relieved by treatment.My kidney function, measured by creatinine levels or clearance, is within the required range.I haven't taken any cancer treatments within the last 4 weeks or five half-lives, whichever is shorter.I have received a COVID-19 vaccine.I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.I have a significant liver condition.I have a serious heart condition.I don't have any health issues that prevent me from taking new medications.I am currently on medication for hepatitis B.I can and am willing to take pills.I understand selinexor or atezolizumab may harm my pregnancy.I haven't had cancer in the last 5 years, except for skin cancer.I have had a condition where my lymphocytes grow abnormally.I am HIV positive, on treatment, and my viral load is undetectable.I do not have any health conditions that would prevent me from taking a new drug.I have an advanced soft tissue sarcoma.My cancer is a type called alveolar soft part sarcoma and cannot be removed by surgery.My ASPS is spreading and cannot be removed via surgery.I have active tuberculosis.I have not received a live vaccine in the last 4 weeks.I am mostly self-sufficient and can carry out daily activities.I am willing to give samples for research.I haven't taken any experimental drugs within the last 28 days.I had hepatitis B in the past but it's resolved now.I have high calcium levels in my blood that are causing symptoms.I am 18 years old or older.I do not have conditions affecting my body's ability to absorb nutrients.I do not have a brain tumor or symptoms from cancer spread to my brain, with some exceptions.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (atezolizumab)
- Group 2: Arm I (atezolizumab, selienexor)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit of participants taking part in this experiment?
"Affirmative. Clinicaltrials.gov documents demonstrate that this research study is actively seeking volunteers, having first been announced on April 21st 2022 and most recently updated November 8th 2022. A total of 77 individuals are required from 3 different medical sites to complete the trial."
Answered by AI
Is this experiment presently seeking participants?
"According to the information provided on clinicaltrials.gov, this trial is actively searching for suitable candidates. The study was initially advertised on April 21st 2022 and has been recently refreshed as of November 8th 2022."
Answered by AI
Has Atezolizumab been officially authorized by the FDA?
"The safety of Atezolizumab has been determined to be a 2 by the team at Power, as there is some evidence that attests its security but no data confirming its efficacy."
Answered by AI
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